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NCT00364832 · ClinicalTrials.gov registry record · Phase 2
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
NCT00364832: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00364832 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00364832, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
Study Summary
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Primary Outcome
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose c
Interventions
- DRUG methoxy polyethylene glycol-epoetin beta [Mircera]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2001-10 |
| Est. Completion | 2005-07 |
| Phase | Phase 2 |
What the finished NCT00364832 record still lists
NCT00364832 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which methoxy polyethylene glycol-epoetin beta [Mircera] is the first listed.
NCT00364832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00364832 about?
NCT00364832 is a clinical study titled "A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.". This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is ...
What is the current status of trial NCT00364832?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2001-10. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00364832?
The interventions under investigation include: methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG).
Who is sponsoring clinical trial NCT00364832?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00364832's enrollment target sits among peer trials
137 527th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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